The purpose of this study is to establish the safety and efficacy of ketotifen/naphazoline ophthalmic solution compared to vehicle and its individual components in alleviating the signs and symptoms of conjunctival allergen challenge (CAC)-induced allergic conjunctivitis.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: March 2010

Intervention(s) in this Clinical Trial

• Drug: Ketotifen/naphazoline
  • One drop of ketotifen/naphazoline in right eye; one drop of ketotifen/naphazoline in left eye at visit 3 and visit 4.
• Drug: Ketotifen/naphazoline and Vehicle
  • One drop of ketotifen/naphazoline in right eye; one drop of vehicle in left eye at visit 3 and visit 4.
• Drug: Ketotifen/naphazoline and Naphazoline
  • One drop of ketotifen/naphazoline in right eye; one drop of naphazoline in the left eye at visits 3 and 4.
• Drug: Ketotifen/naphazoline and Ketotifen
  • One drop of ketotifen/naphazoline in the right eye; one drop of ketotifen in the left eye at visits 3 and 4.
• Drug: Ketotifen and Ketotifen/naphazoline
  • One drop of ketotifen in the right eye; one drop of ketotifen/naphazoline in the left eye at visits 3 and 4.
• Drug: Ketotifen and Vehicle
  • One drop of ketotifen in the right eye; one drop of vehicle in the left eye at visits 3 and 4.
• Drug: Ketotifen and Naphazoline
  • One drop of Ketotifen in the right eye; and one drop of naphazoline in the left eye at visits 3 and 4.
• Drug: Ketotifen
  • One drop of Ketotifen in right eye; one drop of Ketotifen in left eye at visit 3 and visit 4.
• Drug: Naphazoline and Ketotifen/naphazoline
  • One drop of naphazoline in the right eye and one drop of ketotifen/naphazoline in the left eye at visits 3 and 4.
• Drug: Naphazoline and Vehicle
  • One drop of naphazoline in the right eye and one drop of vehicle in the left eye at visits 3 and 4.
• Drug: Naphazoline
  • One drop of naphazoline in right eye; one drop of naphazoline in left eye at visit 3 and visit 4.
• Drug: Naphazoline and Ketotifen
  • One drop of naphazoline in right eye; one drop of Ketotifen in left eye at visit 3 and visit 4.
• Drug: Vehicle and Ketotifen/naphazoline
  • One drop of vehicle in right eye; one drop of ketotifen/naphazoline in left eye at visit 3 and visit 4.
• Drug: Vehicle
  • One drop of vehicle in right eye; one drop of vehicle in left eye at visit 3 and visit 4.
• Drug: Vehicle and Naphazoline
  • One drop of vehicle in right eye; one drop of naphazoline in left eye at visit 3 and visit 4.
• Drug: Vehicle and Ketotifen
  • One drop of vehicle in right eye; one drop of Ketotifen in left eye at visit 3 and visit 4.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Right eye - Ketotifen/naphazoline, left eye - Ketotifen/naphazoline
• Active Comparator: 2
  • Right eye - Ketotifen/naphazoline, left eye - Vehicle
• Active Comparator: 3
  • Right eye - Ketotifen/naphazoline, left eye - naphazoline
• Active Comparator: 4
  • Right eye - Ketotifen/naphazoline, left eye - ketotifen
• Active Comparator: 5
  • Right eye - ketotifen, left eye - Ketotifen/naphazoline
• Active Comparator: 6
  • Right eye - ketotifen, left eye - Vehicle
• Active Comparator: 7
  • Right eye - ketotifen, left eye - naphazoline
• Active Comparator: 8
  • Right eye - ketotifen, left eye - ketotifen
• Active Comparator: 9
  • Right eye - naphazoline, left eye ketotifen/naphazoline
• Active Comparator: 10
  • Right eye - naphazoline, left eye - vehicle
• Active Comparator: 11
  • Right eye - naphazoline, left eye - naphazoline
• Active Comparator: 12
  • Right eye - naphazoline, left eye - ketotifen
• Active Comparator: 13
  • Right eye - vehicle, left eye - ketotifen/naphazoline
• Placebo Comparator: 14
  • Right eye - vehicle, left eye - vehicle
• Active Comparator: 15
  • Right eye - vehicle, left eye - naphazoline
• Active Comparator: 16
  • Right eye - vehicle, left eye ketotifen

Primary Measures

• Ocular itching
  • Time Frame: 3, 5 and 7 minutes post-challenge
    Safety Issue?: No
• Conjunctival redness
  • Time Frame: 7, 15 and 20 minutes post-challenge
    Safety Issue?: No

Secondary Measures

• Ciliary and episcleral redness, chemosis, lid swelling, tearing and ocular mucus discharge.
  • Time Frame: 7, 15 and 20 minutes post challenge
    Safety Issue?: No

Inclusion Criteria:

• Positive history of ocular allergies and positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months.
• Calculated best-corrected visual acuity of 0.7 logMAR or better in each eye as measured using the ETDRS chart.
• Positive bilateral conjunctival allergen challenge(CAC) reaction within 10 minutes of instillation of the last titration of allergen at visit 1.
• Positive bilateral CAC reaction for at least 2 out of 3 time points at visit 2.

Exclusion Criteria:

• Known contraindications or sensitivities to the study medication or its components.
• Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters.
• Use of disallowed medications during the period indicated prior to study enrollment or during the study.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Bausch & Lomb, Inc.

Overall Clinical Trial Officials and Contacts

Overall Contact: Jennifer Lynch (585) 338-6230 jennifer.lynch@bausch.com

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00770133

Study ID Number: 572

ClinicalTrials.gov Identifier: NCT00770133

Health Authority: United States: Food and Drug Administration